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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / March 2026 / K260353

510(k) cleared

Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button

Arthrex, Inc. · Mar 3, 2026 · K260353

FDA cleared the Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button from Arthrex, Inc. on Mar 3, 2026 under K260353, a special 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 3, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Arthrex, Inc. has 8 other decisions in the tracker over the last 12 months: K262357 (Arthrex Bioabsorbable PushLock Suture Anchors), K260624 (Arthrex Radial Head Replacement System), K260018 (Arthrex FiberButton), K260809 (Arthrex Sterile VAL and VAL KreuLock Compression Screw System).

Questions & Answers

What did FDA clear under K260353?

K260353 is the FDA 510(k) for Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button, submitted by Arthrex, Inc.. FDA's decision date was Mar 3, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button?

Arthrex, Inc., based in Naples, FL, is the applicant of record for K260353.

How long did the K260353 review take?

FDA received the submission on Feb 3, 2026 and issued its decision on Mar 3, 2026, 28 days later.

← All decisions in March 2026